PMID- 25409447
OWN - NLM
STAT- MEDLINE
DCOM- 20150930
LR  - 20220309
IS  - 1557-7732 (Electronic)
IS  - 1080-7683 (Linking)
VI  - 31
IP  - 2
DP  - 2015 Mar
TI  - Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: 
      a retrospective safety surveillance study.
PG  - 114-21
LID - 10.1089/jop.2014.0039 [doi]
AB  - PURPOSE: The objective of this study was to collect and evaluate retrospective 
      safety information about the use of besifloxacin ophthalmic suspension 0.6% for 
      the treatment of bacterial keratitis. METHODS: This was a retrospective, 
      postmarketing surveillance study conducted at 10 clinical centers in the United 
      States. The study population included 142 patients treated with besifloxacin 
      ophthalmic suspension 0.6% for bacterial keratitis in one or both eyes. For 
      perspective, data on 85 patients treated at these centers with moxifloxacin 
      ophthalmic solution 0.5% for bacterial keratitis were also included. The analysis 
      was designed to measure the types and rates of adverse events (AEs) reported 
      during the treatment of bacterial keratitis with besifloxacin ophthalmic 
      suspension 0.6%. Other treatment outcomes of interest included the development of 
      corneal scarring and corneal neovascularization, measured or presumed bacterial 
      eradication, ending visual acuity, and duration of pain before and after 
      treatment. RESULTS: There was one reported AE of mild superficial punctate 
      keratitis in a patient using besifloxacin ophthalmic suspension 0.6%. The 
      difference in AE frequencies between groups was not significant (P>0.999). 
      Additional treatment outcomes were similar for both groups. Limitations of this 
      report include the retrospective nature of the study. CONCLUSIONS: These 
      retrospective data suggest that besifloxacin ophthalmic suspension 0.6% was well 
      tolerated when included in the treatment of bacterial keratitis; no serious AEs 
      were reported. A prospective clinical trial is needed to better isolate the 
      contribution of besifloxacin to the therapeutic outcome and to confirm these 
      observations.
FAU - Schechter, Barry A
AU  - Schechter BA
AD  - 1 Florida Eye Microsurgical Institute , Boynton Beach, Florida.
FAU - Parekh, Jai G
AU  - Parekh JG
FAU - Trattler, William
AU  - Trattler W
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141119
PL  - United States
TA  - J Ocul Pharmacol Ther
JT  - Journal of ocular pharmacology and therapeutics : the official journal of the 
      Association for Ocular Pharmacology and Therapeutics
JID - 9511091
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Azepines)
RN  - 0 (Fluoroquinolones)
RN  - 0 (Ophthalmic Solutions)
RN  - BFE2NBZ7NX (besifloxacin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/administration & dosage/adverse effects
MH  - Azepines/*administration & dosage/*adverse effects
MH  - Eye Infections, Bacterial/*drug therapy/microbiology
MH  - Female
MH  - Fluoroquinolones/*administration & dosage/*adverse effects
MH  - Humans
MH  - Keratitis/*drug therapy/microbiology
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/administration & dosage
MH  - Product Surveillance, Postmarketing
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/11/20 06:00
MHDA- 2015/10/01 06:00
CRDT- 2014/11/20 06:00
PHST- 2014/11/20 06:00 [entrez]
PHST- 2014/11/20 06:00 [pubmed]
PHST- 2015/10/01 06:00 [medline]
AID - 10.1089/jop.2014.0039 [doi]
PST - ppublish
SO  - J Ocul Pharmacol Ther. 2015 Mar;31(2):114-21. doi: 10.1089/jop.2014.0039. Epub 
      2014 Nov 19.